GALCODINE LINCTUS

PDF Transcript

IMPORTANT: Peel this label
at corner and read BEFORE
use. Do not tear off, re-fix for
future use.

Care
Codeine
15mg/5ml
Oral Solution
Sugar Free

Codeine Phosphate
Calms dry or irritating coughs

This medicine contains codeine phosphate, which
reduces the desire to cough.

1. Before you use this medicine

Do not use the medicine if you have….

• An allergy to any of the ingredients listed in
section 3.
• Liver disease or severe kidney problems.
• Shallow breath or breathing difficulties.
• A head injury or persistent headache.
• An asthma attack.
• Previously had a blocked bowel • Previously had
an addiction to medicines containing Codeine or
Morphine • If you know that you metabolise very
rapidly codeine into morphine • Previously had a
bad reaction to codeine (a known "ultra-rapid
metaboliser" of codeine) • Or are under 18 years
old • If you are breastfeeding.

Talk to your doctor or pharmacist if you
have….

• Kidney or liver problems (a reduced dose may be
recommended by your doctor) • A history of
asthma or other breathing problems, including
bronchitis • Low blood pressure • Irritable bowel

For the relief of unproductive dry coughs.
Take the solution by mouth.
Adults: Take 1 x 5ml spoonful, four times a
day.
The elderly: Ask your doctor for advice. A
lower dose may be more suitable.
Do not give to children under 18 years old.
WARNING: DO NOT EXCEED THE STATED
DOSE.
If symptoms persist consult your doctor.

Do not store above 25°C.
Keep out of the sight and reach of
children.
Manufactured by the licence holder
Thornton and Ross Ltd., Huddersfield,
HD7 5QH, UK.
PL 00240/0099 23004711
PIP: 296-4633

200ml

Like all medicines, Codeine Linctus Oral Solution
Sugar Free can have side effects, although these
don’t affect everyone.
Important side effects
Codeine is transformed to morphine in the liver by an
enzyme. Morphine is the substance that produces
pain relief. Some people have a variation of this
enzyme and this can affect people in different ways.
In some people, morphine is not produced or
produced in very small quantities, and it will not
provide enough pain relief. Other people are more
likely to get serious side effects because a very high
amount of morphine is produced. If you notice any of
the following side effects, you must stop taking this
medicine and seek immediate medical advice: slow or
shallow breathing, confusion, sleepiness, small pupils,
feeling or being sick, constipation, lack of appetite.
Other possible side effects are:
• Feeling or being sick • Dizziness or vertigo
• Constipation • Loss of appetite • Fits • Feeling unwell

P

Pregnant or breastfeeding….

Codeine Oral Solution Sugar Free should not be
used in pregnancy unless the doctor has told you to
do so. Do not take codeine while you are
breastfeeding. Codeine and morphine passes into
breast milk.

Driving and using machines….

This medicine may cause drowsiness or dizziness.
If you are affected do not drive or operate machinery.
The medicine can affect your ability to drive as it
may make you sleepy or dizzy.
• Do not drive while taking this medicine until you
know how it affects you.
• It is an offence to drive if this medicine affects your
ability to drive.
• However, you would not be committing an offence if:
◦ The medicine has been prescribed to treat a
medical or dental problem and
◦ You have taken it according to the instructions given
by the prescriber or in the information provided
with the medicine and
◦ It was not affecting your ability to drive safely.
Talk to your doctor or pharmacist if you are not sure
whether it is safe for you to drive while taking this
medicine.
23004711

Talk to your doctor or pharmacist if you
are taking….

• MAOIs (monoamine oxidase inhibitors) for
depression, selegiline for Parkinson's Disease, or
the antibiotic linezolid, or you have taken them
within the last two weeks • Alcohol
• Metoclopramide or domperidone for nausea and
vomiting • Quinidine, or mexiletine for irregular
heartbeat • Any tranquillisers, antidepressants,
sedatives, painkillers, general anaesthetics,
sedating antihistamines or sleeping tablets • Any
medicine for mental illness • Cimetidine for
stomach ulcers • Sodium oxybate for sleeping
disorders • Rifampicin for tuberculosis.

• This product contains parahydroxybenzoates and
sunset yellow dye which may cause allergic
reactions (possibly delayed).
• It contains a small amount of ethanol (alcohol),
less than 100mg per 5ml.

2. Possible side effects

Peel

• Muscle twitching or stiffness • Drowsiness
• Disturbed sleep • Difficulty in passing water • Dry
mouth • Sweating • Headache • Facial flushing
• Fluid retention (e.g. swollen ankles and feet)
• Abnormal heartbeat • Feeling faint when standing
up • Slow, shallow breathing • Low body heat
• Hallucinations • Mood changes • Feeling restless or
confused • Pinpoint pupils or other problems
with eyesight • Abdominal pain(including pain
caused by inflammation of the pancreas (pancreatitis)
or bile duct problems (biliary spasm))
• Prolonged use may worsen irritable bowel
syndrome • Ureteric spasm (urine tube problem
causing abdominal or lower back pain) • Low
sexual urge • Allergic reactions such as itching and
a rash • Elderly people may experience diarrhoea,
stomach pain or a blocked bowel. Prolonged use
may lead to addiction, dependence and tolerance
(the medicine loses its effect).
If you notice these or any other side effects, stop
use and tell your doctor or pharmacist. They will tell
you what to do.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the
safety of this medicine.

3. Further information

If you accidentally take too much see a doctor
straight away. Take the pack with you to show which
medicine you have swallowed.
• Do not use after the expiry date. The expiry date
refers to the last day of that month.
• Return any unused medicine to the pharmacy for
disposal.
The active ingredient per 5ml is: codeine
phosphate 15mg.
The other ingredients are: citric acid monohydrate
(E330), sodium methyl, ethyl and propyl
parahydroxybenzoates (E219, E215, E217), ethanol,
sunset yellow dye (E110), saccharin sodium,
carmellose sodium, levomenthol, condensed milk
flavour (contains propylene glycol), orange flavour,
glycerol (E422) and purified water.
What the medicine looks like
Codeine Oral Solution Sugar Free is a yellow syrupy
liquid.
It is supplied in 200ml bottles.
Text revised: April 2016
23004711

Datamatrix: 23004711
VERIFIED

MHRA Header Box

Braille reads:

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oral solution
sugar free
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Colours Used

Care Codeine 15mg/5ml Oral Solution
Sugar Free

Process Cyan

Braille BQ

Component

Landscape peelable label

Process Magenta

Helvetica

Pack Size

200ml

Process Yellow

Helvetica Neue

IG Code

23004711

Process Black

Optima BQ

Dimensions

65mm x 170mm

Keyline (Non-printing)

Times New Roman

Proof No.

1

Date

Braille

12.04.2016

Print free area (Non-printing)

PCP Header Box
Operator

Braille Warning! MPS cannot accept responsibility for any errors in this proof after
approval by the customer.
Whilst extreme care is taken in the setting of Braille, the customer must take the
final responsibility for its accuracy.
There is no single European Braille authority and there are many different Braille
formats in existence, with country specific characters.
This Braille is set to the Marburg Medium format unless you have requested
otherwise.
When you sign this proof you are signifying full approval of the Braille text and
specification.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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